AbbVie announces first patient dosed in phase 3 trial of upadacitinib in hidradenitis suppurativa
AbbVie has announced that the first patient has been dosed in its phase 3 Step-Up trial assessing Rinvoq (upadacitinib) for the treatment of hidradenitis suppurativa (HS). The trial aims to evaluate the safety and efficacy of the drug in adults and adolescents with moderate to severe HS.
HS is estimated to impact up to 1% of the global population, with patients experiencing increasing disease severity for an average of seven-to-ten years before gaining an accurate diagnosis. Currently the disease has no cure and there are limited treatment options.
The Step-Up trial is aiming to enroll 1,300 patients across 275 sites worldwide, and will take place over three phases. The primary endpoint of the trial will assess the percentage of participants reaching HS clinical response 50, meaning a 50% reduction in the total abscess and inflammatory nodule count with no increase in abscess count and no increase in draining fistula count compared to a baseline at week 16 of the trial.
Roopal Thakker, MD, senior vice president of development and regulatory affairs and chief medical officer at AbbVie, commented: “HS is a chronic, inflammatory disease that often leads to irreversible skin damage and extreme pain for patients. Leveraging our proven expertise in immunology and experience in HS, we continue to drive innovation and pursue advancement of care in patient populations with difficult-to-treat immune-mediated diseases that have limited therapeutic options.”
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